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510(k) Data Aggregation
(82 days)
PMT NEW BEGINNINGS GELSHAPES & AMEND
Management of hypertrophic and keloid scars.
PMT®'s Model 5100 New Beginnings™ GelShapes™ & Amend™ consist of a solid piece of low durometer medical grade silicone with a thin, high durometer silicone backing. Certain GelShapes™ & Amend™ also have reinforcement material for added strength. The silicone gel sheeting is used on hypertrophic or keloid scars in order to soften or lighten the color of these scars. The model 5100 New BeginningsTM GelShapes™ & Amend™ are used only externally and on intact skin.
The provided text is a 510(k) premarket notification for the PMT® New Beginnings™ GelShapes™ & Amend™ device, which is a silicone gel sheeting used for the management of hypertrophic and keloid scars. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies with acceptance criteria, human reader studies, or detailed ground truth methodologies typically associated with software-as-a-medical-device (SaMD) or AI-powered devices.
Therefore, much of the requested information regarding acceptance criteria, specific study design elements (sample sizes, expert qualifications, adjudication, MRMC, standalone performance), and detailed ground truth establishment is not present in this 510(k) submission.
Here's an attempt to answer the questions based on the available information, noting when the information is not provided:
Acceptance Criteria and Study for PMT® New Beginnings™ GelShapes™ & Amend™
This 510(k) submission (K972597) for the PMT® New Beginnings™ GelShapes™ & Amend™ device demonstrates substantial equivalence to legally marketed predicate devices, rather than establishing specific performance acceptance criteria through clinical studies in the way an AI/software device would. The "study" here refers to the documentation and claims made within the 510(k) to support this substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as such for this 510(k)) | Reported Device Performance |
|---|---|
| Premarket Notification (510(k)) Goal: Substantial Equivalence to Predicate Devices | The FDA determined the device is substantially equivalent to devices marketed prior to May 28, 1976, or to reclassified devices. This implies that the device performs similarly to or has the same intended use as predicate gel sheeting products (e.g., ReJuveness, McGhan Medical Corporation, Geligne Medical, Medical Z, CUI Corporation, Biodermis). |
| Intended Use: Management of hypertrophic and keloid scars | The device's stated "Indications For Use" is "Management of hypertrophic and keloid scars." This matches the indication of predicate devices. |
| Device Description: Solid low durometer medical-grade silicone with thin, high durometer silicone backing, some with reinforcement. Used externally on intact skin. | The device consists of "a solid piece of low durometer medical grade silicone with a thin, high durometer silicone backing." Certain variations have "reinforcement material for added strength." This description aligns with the physical characteristics expected of gel sheeting for scar management, similar to predicate devices. |
| Sterilization: Overkill method to 10⁻⁶ SAL (if sterile) | "The sterilization method employed is the overkill method and validated to the terminal process endpoint probability of a nonsterile unit of 10⁻⁶." This meets standard sterilization validation practices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not applicable or not specified. This 510(k) submission does not describe a specific clinical "test set" or study on patients to evaluate performance against acceptance criteria. The submission relies on the established use and safety profile of similar predicate devices.
- Data Provenance: Not applicable, as no new clinical data from a "test set" is presented in the summary for performance evaluation. The submission refers to "a number of different articles within this submission" regarding the common procedure of managing scars with gel sheeting, implying existing literature, but does not detail a specific new study's data provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. As there is no specific "test set" and ground truth validation study described in the 510(k) summary, no experts were detailed for this purpose.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set or adjudication process is described in the 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study was not conducted for this 510(k) submission. This is a medical device (silicone sheeting), not an AI/software diagnostic tool that would typically involve MRMC studies to evaluate human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical product (gel sheeting), not an algorithm or software. It does not have "standalone" algorithm performance. Its efficacy is based on its physical properties and interaction with biological tissue for scar management, likely supported by general understanding and existing literature on silicone gel sheeting.
7. The Type of Ground Truth Used
- Not explicitly defined. For a physical device like silicone gel sheeting, "ground truth" for efficacy would typically be established through clinical outcomes (e.g., blinded assessments of scar appearance, pliability, color, patient reported outcomes) in well-designed clinical trials. This 510(k) relies on the "common procedure" and "equivalence" to predicate devices whose efficacy is presumably well-established clinically. No specific ground truth methodology for a new study is detailed here.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/machine learning model, so there is no "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established
- Not applicable. No training set exists for this device.
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